You may have heard or read about the recent FDA Panel hearings on Plastic Surgical Devices (breast implants) that took place the end of March. The primary information points from the Panel include:
- Recommendations on MRI screening of silicone breast implants including a consensus to remove the current FDA MRI screening recommendations, and to adopt screening recommendations that begin between 5 and 6 years post surgery, then every 2-3 years after that. The use of alternatives to MRI were discussed, and ultrasound was recommended as an acceptable alternative for screening asymptomatic patients. For symptomatic patients as well as patients with equivocal ultrasound results, the Panel recommended MRI for detection of silicone implant ruptures.
- A recommendation for further study of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a lymphoproliferative disorder (LPD) associated with macrotextured implants, and Breast Implant Illness (BII), a term used by women connected through social media groups who have implants and self-identify and describe a variety of symptoms that they feel are directly related to their saline or silicone, textured or smooth implants .
- Recommendation for development of industry/physician/patient generated and shared Informed Consent checklists.
- A recommendation for the use of registries, the importance of capturing patient-reported outcomes, and the need to strike the right balance between data collection requirements and optimizing participation in the registry.
- Recommendation for the need for controlled studies on a surgical mesh called acellular dermal matrix (ADM) in reconstruction patients.
The FDA Panel provided its recommendations during the meeting, a 4 page summary of which you can find at this link:
In addition, here are links to more information about BIA-ALCL and BII:
Of course, if you have further questions or would like personalized information and recommendations, please call my office for an appointment. (561) 833-6688.
The FDA last updated it’s website on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in March 2017. (See corresponding blog on my website for March 2017). On March 21, 2018 the FDA announced an update to its website regarding the number of cases of BIA-ALCL submitted to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database. It estimated the risk for a woman with textured implants to develop BIA-ALCL at 1:3,817 to 1:30,000. My two specialty societies, The American Society of Plastic Surgery (ASPS) and The American Society for Aesthetic Plastic Surgeons (ASAPS), have been working with the FDA to compile a Registry. The following is a summary of the FDA update.
The update acknowledges the FDA’s position that it remains difficult to determine the exact number of BIA-ALCL cases in the United States, and it notes that 414 medical device reports (MDR) have been submitted to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database as of March 21, 2018. This represents an increase of more than 15 percent since the last update in March 2017. It’s important to note that these do not necessarily represent new cases – rather, they are reports added since the previous update. The FDA acknowledges that, while its MDR system is a valuable source of information, it relies on accurate reporting and, therefore, may contain incomplete, inaccurate, untimely, unverified or biased data.
In addition to citing the increase in the number of BIA-ALCL cases reported, the FDA reports that, based on current medical literature, the risk for a woman with textured implants to develop BIA-ALCL is 1:3,817 to 1:30,000. This range is consistent with recent ASPS and ASAPS updates to membership, and the FDA update calls for no changes in recommendations regarding breast implants. For patients with breast implants, the FDA states there is no need to change routine medical care and follow-up, and there is no need to test asymptomatic patients.
Although the FDA indicates it has received 30 reports associated with smooth surfaces, to date there have been no confirmed smooth surface-only cases reported to Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE). As of March 21, 2018, 195 unique confirmed U.S. cases of BIA-ALCL have been reported to the PROFILE registry, a joint collaboration between ASPS, The Plastic Surgery Foundation (PSF), ASAPS, The Aesthetic Surgery Education and Research Foundation (ASERF), and the FDA. It’s important to note that the MAUDE database may contain limited and potentially inaccurate adverse event reports, and it may not represent the true number of U.S. cases, as some entries are duplicates and not all cases are confirmed as BIA-ALCL.
The FDA update confirms previous ASPS and ASAPS communications to membership that BIA-ALCL remains a rare condition that occurs most frequently in patients who have breast implants with textured surfaces. The report also reiterates that patients should discuss with their health-care provider the benefits and risks of textured-surface versus smooth-surface implants. The FDA highlights the World Health Organization recognition of BIA-ALCL, and the standardized diagnosis and treatment guidelines established by The PSF, The ASERF, and the National Comprehensive Cancer Network (NCCN).
The FDA recommends that all cases of BIA-ALCL be reported to the FDA and to the PROFILE registry. The agency has also updated the content and format of its webpage for breast implant post-approval studies, in order to make current information about these important studies easier for patients to read and understand.
You may have heard recent media reports regarding breast implants and a rare form of cancer. The FDA recently updated information regarding this disease (Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)). My specialty societies, The American Society of Plastic Surgery and the American Society for Aesthetic Plastic Surgery, are working closely with the FDA in monitoring the disease.
BIA-ALCL is not a breast cancer, but a rare and treatable T-cell lymphoma (a type of non-Hodgkins lymphoma) that involves the scar tissue around the implant (capsule) and usually develops as a fluid accumulation (non-traumatic seroma) around a breast implant.
The lifetime risk for this disease appears to be about 1 case for every 30,000 textured implants. This equates to a 0.003 percent risk. Thus far, there have been no confirmed cases of BIA-ALCL in women who have had only “smooth surface” breast implants.
The FDA is not recommending prophylactic removal of textured implants. Rather, the FDA recommends, as do I, that every woman conduct regular self breast examination. If you develop a seroma or a lump in your breast and do not have a doctor familiar with BIA-ALCL, contact my office right away. I will comprehensively evaluate you and order the appropriate tests to determine if any treatment is indicated.
Women who develop BIA-ALCL can often be cured by simply removing the implant and the capsule around the implant (capsulectomy). Some patients may require additional treatment (such as radiation or chemotherapy). Following removal and capsulectomy, replacement with a smooth surface implant may be an option.
For additional information about BIA-ALCL, I am happy to answer your questions or you may consult the following websites/links: The American Society of Plastic Surgery website at www.plasticsurgery.org/alcl or the FDA updated website at
During a typical consultation with a patient interested in breast augmentation, I discuss options including incision placement, pocket placement, and, of course, implant options. Implant options include silicone versus saline, low, moderate versus high profile, smooth versus textured surface, and round versus anatomic shape. Women frequently are under the assumption that an anatomic shaped implant is better than a round implant, but is this actually true? It has always been my experience and thus, my opinion, that if a prospective augmentation patient has at least some shape to her own breasts, that she merely needs enhancement of that shape, and therefore she can get a good result with a round implant. And now I have a study that corroborates my experience. The following is hot off the press from my Plastic Surgery specialty society’s recognized journal:
Round or ‘Shaped’ Breast Implants? Even Plastic Surgeons Can’t Tell the Difference
Looking at before-and-after photos, plastic surgeons and plastic surgical nurses can’t tell whether breast augmentation surgery was done using conventional round implants or newer anatomically shaped implants, reports a study in the January issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS).
At least in the specific group of patients studied, the results of breast augmentation using round versus shaped implants are indistinguishable, according to the new research, led by Dr. Carlos Rubi of The IMED Hospital Department of Plastic Surgery, Valencia, Spain. The results suggest that routine use of increasingly popular “teardrop-shaped” implants is not justified.
No Visible Difference in Results between Implant Types in Before-and-After Photos
In the study, 30 plastic surgeons and plastic surgery nurses reviewed preoperative and postoperative photos of 30 women who had undergone breast augmentation with round or anatomically shaped implants—15 patients in each group. The two groups were otherwise similar: all procedures were done using silicone implants, placed under the muscle (subpectoral), with an average implant size of about 300 cc.
For each set of photos, the surgeons and nurses judged whether the procedure was done using round or shaped implants. The goal was to determine if the aesthetic results of round versus shaped implants could be differentiated from each other.
For all observations, there was about a 50-50 chance that the surgeons and nurses could correctly identify the type of implant used. There was a lack of agreement not only between different raters, but also for individual raters comparing the same images several weeks later.
Plastic surgeons performed slightly better than nurses in identifying the type of implant—possibly because they could deduce which type would likely be recommended, based on the “before” photos.
Introduced recently, teardrop-shaped implants have become increasingly popular for breast augmentation surgery. “A widespread idea is that the anatomically shaped implants give more natural results than the round implants,” Dr. Rubi and coauthors write.
But the new study shows that even plastic surgeons and plastic surgery nurses cannot tell the difference between the final outcomes of breast augmentation with round versus shaped implants, in a group of patients with otherwise similar characteristics. The results add to a previous study that showed similar outcomes with the two implant types used for breast reconstruction.
The inability to tell the difference between implant types for breast augmentation questions the preference for shaped implants—especially since they cost more and carry a risk of complications related to implant rotation, compared to round implants. “The systematic use of anatomically shaped implants is not justified,” Dr. Rubi comments. “Natural results are achieved with both types of implants.”
KYBELLA® is the first and only injectable drug approved by the FDA (in 2015) “for the treatment of moderate to severe convexity or fullness associated with submental fat in adults”. In lay terms, this drug improves the appearance and profile of moderate to severe fat below the chin, or “the double chin”. KYBELLA® is deoxycholic acid (DOCA), a cytolytic drug, which, when injected into the tissue, physically destroys the cell membrane causing lysis, i.e., permanent death to the fat cell so it can no longer store or accumulate fat, regardless if the origin of fat is genetic, weight gain or aging.
This is an office procedure involving multiple injections with a very tiny needle into the fatty area below the chin. A topical anesthetic is applied beforehand for comfort. Afterwards, an ice pack is placed to reduce swelling. While normal activities may be resumed, because of the likelihood of swelling, social downtime for a few days is recommended. The average treatment uses 2 to 4 vials, and the average patient requires 2-4 treatments at monthly intervals. Once the result is achieved, further treatment is not necessary. This is a non-surgical alternative to liposuction in this area of the body!
The most common adverse reactions (>20%) include injection site edema/swelling, bruising/hematoma, pain, numbness, erythema/redness and induration/firmness. Edema/swelling was reported as mild in 79.5%, moderate in 19%, and severe in 1.5%. Ice packs, head elevation and time resolve this reaction. Risks include frequent bruising/hematoma reported in 72%. Marginal mandibular nerve injury resulting in an asymmetric smile was reported in 4%; spontaneous resolution occurred in a range of 1-298 days, median 44 days. Dysphagia (difficulty swallowing) was reported in 2%; spontaneous resolution occurred in a range of 1-81 days, median 3 days.
Deoxycholic acid (DOCA) is a naturally occurring molecule in the body that aids in the breakdown and absorption of dietary fat. Endogenous DOCA (that which normally circulates in the body) is a product of cholesterol metabolism and is excreted intact in the feces. DOCA from KYBELLA® joins the endogenous bile acid pool in the liver circulation and is excreted along with the endogenous DOCA.
Nationwide cosmetic surgery chain Lifestyle Lift apparently has closed at least 40% of its clinics and may file for bankruptcy. The corporation treats plastic surgery more like a commodity…the model is based on selling trademarked cosmetic procedures to physicians in return for patient referrals, marketing, and training. They claim to offer less invasive, cheaper facelifts and a shorter recovery. “Real” Plastic Surgeons do similar procedures, but call them “mini-facelifts”. Because “real” plastic surgeons have extensive training, their results are usually better with less scarring and longer lasting. This is just another example that “Cheaper is not always better!” See more information on the following links:
From Plastic Surgery SmartBrief (03/10/15): Fast Face-Lift Firm Closes Clinics
Nationwide cosmetic surgery chain Lifestyle Lift has shuttered clinics and might file for bankruptcy. Office staff at a North Carolina clinic that closed said they are working for free to ensure patients get necessary follow-up care. WCNC-TV (Charlotte, N.C.) (3/5), WWSB-TV (Sarasota, Fla.) (3/6)
If you think the cost of good Plastic Surgery is expensive, consider the cost of bad Plastic Surgery! This woman who was interested in enlarging her breasts opted against traditional breast augmentation surgery for a cheaper procedure….she choose silicone injections. Cheap ended up costing the woman her breasts. The old saying, “You get what you pay for” still rings true! Click on the following link for the story http://www.foxnews.com/health/2015/01/05/botched-breast-enhancement-performed-by-non-certified-plastic-surgeons-leads/
Those of you who know my Plastic Surgery philosophy and expertise are aware I tend to be “conservative”… less is generally best. I avoid making my patients look “Fake, (over)Filled, or Frozen(too much BOTOX®). This article about how to avoid “the 3 F’s” written by Project Beauty, a good resource about cosmetic procedures for the non-professional sponsored by the American Society for Aesthetic Plastic Surgery, one of my specialty societies, eloquently discusses the problems with “over treatment”. BOTOX® and injectable fillers were originally used by Plastic Surgeons as non-invasive procedures to create “the Liquid Facelift”. But too much of a good thing has resulted in unnatural appearances, ranging from “the zombie”, to “balloon cheeks”, “monkey” or “duck” lips, and other strange looks.
What happens when beauty bargains go wrong? Plastic Surgery is NOT the thing to bargain shop for because you may get alot more than you bargained for!
In “Dying to be Beautiful: Beauty Trends That Can Prove Lethal”, Katie Couric examines what happens when beauty bargains go wrong during her daytime talk show “Katie” which recently aired. A few patients who have suffered severe disfigurement from undergoing plastic surgery from non board-certified plastic surgeons were profiled.
As an extension of the American Society of Plastic Surgeons public education campaign efforts “Do Your Homework”, Immediate Past President of my specialty society, Malcolm Z. Roth, M.D., F.A.C.S. appeared on “Katie”. Dr. Roth talked about the importance of choosing a board certified plastic surgeon. Click on this link to view http://echo4.bluehornet.com/ct/19560488:21862028138:m:N:1767211534:8434FE84079DA42D0145FBA0EB978F0Fttp